Malignant Biliary Obstruction, Pancreatic Cancer
Conditions
Keywords
pancreatic cancer, malignant biliary obstruction, preoperative biliary drainage, ERCP, fully covered self-expandable metal stent, plastic stent
Brief summary
This study is a multicenter, randomized clinical trial designed to compare the effectiveness and safety of a modified 8-mm fully covered self-expandable metal stent (FCSEMS) with a conventional plastic stent for preoperative biliary drainage in patients with pancreatic cancer and malignant biliary obstruction. In patients who require biliary drainage before surgery, stent placement is commonly performed using endoscopic retrograde cholangiopancreatography (ERCP). However, the optimal stent type remains uncertain. Participants will be randomly assigned to receive either the modified FCSEMS or a plastic stent. The primary objective is to evaluate the rate of stent-related complications requiring reintervention before surgery. Secondary outcomes include stent patency, adverse events, and surgical outcomes. The results of this study are expected to help determine the most appropriate stent strategy for patients undergoing surgery for pancreatic cancer.
Detailed description
Pancreatic cancer is a highly aggressive malignancy with a poor prognosis, and many patients present with malignant biliary obstruction at the time of diagnosis. Preoperative biliary drainage is frequently required in patients undergoing neoadjuvant chemotherapy or delayed surgery to relieve jaundice and prevent complications such as cholangitis. Endoscopic retrograde cholangiopancreatography (ERCP) with stent placement is the standard approach for biliary drainage. Plastic stents (PS) are widely used due to their low cost and ease of removal; however, they are associated with a relatively short patency and frequent occlusion, often necessitating repeated interventions. Fully covered self-expandable metal stents (FCSEMS) have demonstrated longer patency, but concerns remain regarding adverse events and potential impact on subsequent surgical procedures. A modified non-flared 8-mm diameter FCSEMS has been developed to reduce complications while maintaining adequate patency. Its design includes a dumbbell-shaped structure with a narrower central portion to prevent migration, a fully covered membrane to reduce tissue ingrowth, and a retrieval lasso to facilitate removal. This design may offer advantages over both conventional FCSEMS and plastic stents in the preoperative setting. This study is a prospective, multicenter, open-label, randomized controlled trial designed to compare a modified 8-mm FCSEMS with a plastic stent for preoperative biliary drainage in patients with pancreatic cancer and malignant biliary obstruction. Eligible patients will be randomly assigned in a 1:1 ratio to receive either the modified FCSEMS or a plastic stent. The primary endpoint is the stent-related non-event rate at the time of surgery, defined as the proportion of patients who do not require reintervention due to stent-related complications before surgery. Secondary endpoints include the incidence of recurrent biliary obstruction, time to recurrent biliary obstruction, stent-related adverse events, technical success, surgical outcomes, and overall survival. All procedures will be performed using standard ERCP techniques by experienced endoscopists. Patients will be followed until surgery and throughout the postoperative period to assess clinical outcomes. The findings of this study are expected to provide evidence to guide optimal stent selection for preoperative biliary drainage in patients with pancreatic cancer, particularly in the context of neoadjuvant treatment strategies.
Interventions
DEVICEModified 8-mm Fully Covered Self-Expandable Metal Stent
A modified non-flared 8-mm fully covered self-expandable metal stent designed for preoperative biliary drainage. The stent features a dumbbell-shaped structure with a narrower central portion to reduce migration, a fully covered membrane to prevent tissue ingrowth, and a retrieval lasso to facilitate removal. It is deployed via ERCP across the malignant biliary stricture.
DEVICEPlastic stent
A conventional 8.5-Fr plastic biliary stent used for preoperative biliary drainage. The stent is placed via ERCP across the malignant biliary stricture and represents the standard treatment option, although it is associated with shorter patency and a higher risk of occlusion compared to metal stents.
Sponsors
Soonchunhyang University Hospital
Samsung Medical Center
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This study is conducted as an open-label trial. Due to the nature of the endoscopic procedures and the visible differences between the stent types, blinding of participants, care providers, and investigators is not feasible.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to receive either a modified 8-mm fully covered self-expandable metal stent or a plastic stent for preoperative biliary drainage.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Patients with resectable, borderline resectable, or locally advanced pancreatic cancer with distal malignant biliary obstruction requiring endoscopic biliary drainage 3. Biliary stricture located ≥ 2 cm below the hepatic hilum 4. Serum bilirubin ≥ 3 mg/dL 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 6. Ability to provide written informed consent
Exclusion criteria
1. Presence of distant metastasis 2. Prior biliary stent placement for biliary obstruction 3. Requirement for duodenal stent placement due to gastric outlet obstruction 4. Estimated life expectancy \< 3 months 5. Inability to undergo ERCP 6. Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study outcomes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stent-Related Non-Event Rate at Surgery | From stent placement to the time of surgery | The proportion of patients who do not require reintervention due to stent-related complications from stent placement until the time of surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent Biliary Obstruction Rate | From stent placement to RBO, assessed up to 24 months | The proportion of patients who develop recurrent biliary obstruction requiring reintervention |
| Time to Recurrent Biliary Obstruction | From stent placement to first RBO, assessed up to 24 months | Time from stent placement to the occurrence of recurrent biliary obstruction |
| Stent-Related Adverse Events | Within 30 days after procedure | Incidence of adverse events related to stent placement, including pancreatitis, cholangitis, cholecystitis, bleeding, perforation, or stent migration |
| Technical Success Rate | During the index procedure | Successful placement of the stent across the target biliary stricture in the intended position |
| Surgery Completion Rate | Up to surgery | The proportion of patients who undergo planned surgical resection after biliary drainage |
| Overall Survival | From procedure to death from any cause, assessed up to 24 months | Time from stent placement to death from any cause |
Contacts
CONTACTIl Sang Shin, Assistant Professor
Outcome results
None listed